[Federal Register Volume 61, Number 26 (Wednesday, February 7, 1996)]
[Proposed Rules]
[Pages 4597-4598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2595]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1220
[Docket No. 96N-0011]
Tea Importation Act; Tea Standards
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is announcing how it
intends to implement the Tea Importation Act (the Act) in the wake of
the agency's appropriation for fiscal year (FY) 1996, which provides
that none of the funds appropriated may be used to operate the Board of
Tea Experts (the board). Without a board to provide recommendations for
standards of purity, quality, and fitness for consumption of imported
teas, FDA has decided to solicit public recommendations for the tea
standards that will be effective beginning May 1, 1996. In addition,
FDA requests comments on the appropriateness of this approach to
setting such standards.
DATES: Written comments and other material considered relevant,
including samples that the agency may use as standards, by April 8,
1996. FDA proposes that any final standards that are adopted in this
proceeding will be effective on May 1, 1996.
ADDRESSES: Submit written comments and any tea samples to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Michelle A. Smith, Center for Food
Safety and Applied Nutrition (HFS-158), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5099.
SUPPLEMENTARY INFORMATION: Section 3 of the Act (21 U.S.C. 43) states:
The Secretary of [Health and Human Services], upon the
recommendation of the board of experts provided in section 2 of this
title, shall fix and establish uniform standards of purity, quality,
and fitness for consumption of all kinds of tea imported into the
United States, and shall procure and deposit in the customhouses of
the ports of New York, Chicago, San Francisco, and such other ports
as he may determine, duplicate samples of such standards.
Under the Act and the regulations that FDA has adopted to implement it,
FDA sets such standards annually (see 21 U.S.C. 42 and 21 CFR 1220.40).
No tea that is inferior in purity, quality, or fitness for consumption
to the standard established by FDA may be brought into this country (21
U.S.C. 41).
Public Law 104-37, which contains FDA's appropriation for FY 1996,
states that: ``None of the funds appropriated or made available to the
Food and Drug Administration in this Act shall be used to operate the
Board of Tea Experts.'' This provision creates a significant problem
for the agency since members of the board cannot be appointed, nor its
activities supported by FDA. Nonetheless the Act remains in effect.
Thus, FDA has a continuing obligation to implement it. This obligation
is underscored by the fact that Congress rejected a broader limitation
on the agency's ability to expend funds to implement the Act that
appeared in the version of the appropriations bill that passed the
Senate (see H. Rept. 104-268, 104th Cong., 1st sess. 38 (1995)).
However, without the benefit of the advice of the board, the agency is
faced with the question of how it will arrive at the standards required
under the Act for imported teas.
In considering this question, FDA identified three options. First,
it could do nothing to implement the Act. The agency rejected this
option because it would be inconsistent with the apparent intent of
Congress, and because it would mean that it would ostensibly be
unlawful to bring or import into the United States any merchandise
identified as tea. Even though the agency could, as an exercise of its
enforcement discretion, do nothing about the latter fact, FDA considers
it unfair and unwise to allow such a situation to emerge. Thus, the
agency considers it incumbent on itself to continue to implement the
Act in a manner that is consistent with law.
The second option that the agency identified was to ask the
Department of Health and Human Services, of which FDA is a part, to
operate the board with funds not appropriated in Pub. L. 104-37. The
agency rejected this option because it is not consistent with the
spirit of Congress's action, and because the Department is likely to
have little ability to assume this financial and resource obligation.
The third option that FDA considered was to substitute public input
for the recommendations of the board. This option is not inconsistent
with the law. The requirement in 21 U.S.C. 43 is that the Secretary
(and, by delegation, FDA) fix and establish standards for teas. While
the law provides that the board is to provide recommendations to FDA,
there is nothing in the Act that says that the agency can only
establish such standards based on the board's recommendations. Thus,
the agency is not precluded from relying on other sources of
information. The agency considers it likely that the information that
it receives in response to a request for comments will allow it to set
appropriate standards for tea. Moreover, once the agency sets such
standards, tea can continue to come into this country lawfully, limited
only by the standards that FDA sets.
Based on these considerations, FDA is seeking public comment on the
standards of purity, quality, and fitness for consumption of tea that
it is to set under 21 U.S.C. 43 for the year beginning on May 1, 1996.
FDA requests that interested persons submit all material that they
consider relevant, including samples that the agency may use as
standards. FDA will evaluate the information that it receives, and,
based on that evaluation, it intends to arrive at the standards that
will apply to tea shipped from abroad after May 1, 1996, until April
30, 1997.
In addition to comments on what the standards should be, FDA
solicits comment on the process that it has instituted. FDA solicits
comments on its
[[Page 4598]]
tentative view that this course of action is consistent with both the
Act and Pub. L. 104-37. Any comments that disagree should set forth the
basis for the view. The agency also solicits comments on whether there
are any other options that the agency can follow that are preferable to
the one that it has tentatively decided to pursue and yet that are
still consistent with the two laws in question.
Dependent on the comments, information, and other material
(including tea samples) submitted in response to this proposal, FDA is
hopeful of being able to proceed directly to a final rule that
establishes the applicable tea standards.
Environmental Impact
The agency has determined under 21 CFR 25.24(b)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
Analysis of Impacts
FDA has examined the impact of this proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs Federal agencies to assess the costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects; distributive impacts; and equity). According to Executive
Order 12866, a regulatory action is ``economically significant'' if it
meets any one of a number of specified conditions, including having an
annual effect on the economy of $100 million or adversely affecting in
a material way a sector of the economy, competition, or jobs. A
regulation is considered ``significant'' under Executive Order 12866 if
it raises novel legal or policy issues. The Regulatory Flexibility Act
requires Federal agencies to minimize the economic impact of their
regulations on small businesses.
FDA finds that this proposed rule is neither an economically
significant nor significant regulatory action as defined by Executive
Order 12866. In compliance with the Regulatory Flexibility Act, FDA
certifies that this proposed rule, if promulgated, will not have a
significant impact on a substantial number of small businesses.
Under the current standard setting procedure, the public provides
relevant information and material, such as tea samples, to the board,
which then makes recommendations to FDA. Based on these
recommendations, FDA sets tea standards for that year. Under the
proposed system, the public may send information and material directly
to FDA, which will set tea standards for that year without the
recommendations of the board. This change in the standard setting
process is not expected to lead to any additional compliance costs.
The primary benefit of the proposed method of setting tea standards
is that it allows those standards to be set in the absence of
recommendations by the board. FDA is required to set tea standards
under Section 43 of the Act (21 U.S.C. 43).
FDA requests comments on the economic consequences of the proposed
method of setting tea standards, the various ways in which tea samples
and other information submitted to FDA may best be used to set tea
standards, and on means by which the costs of the proposed standard
setting process may be minimized and the benefits maximized.
Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
reporting, recordkeeping, labeling, or other third party disclosure
requirements; thus, there is no ``information collection''
necessitating clearance by the Office of Management and Budget.
Interested persons may, on or before April 8, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this regulation. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday. FDA believes that 60 days is an
appropriate amount of time for meaningful comments to be submitted and
for the agency to meet its statutory obligation to establish new
standards for imported tea by May 1, 1996.
Dated: January 31, 1996.
William K. Hubbard,
Associate Commisioner for Policy Coordination.
[FR Doc. 96-2595 Filed 2-2-96; 10:52 am]
BILLING CODE 4160-01-F
